Medicare Modifiers: The Impact on Clinical Research

1. Medicare Modifiers:  The Impact on Clinical Research Susie Bullock, RN, MPH, OCN, CCRP Manager Clinical Research Support Center MD Anderson Cancer Center

2. Overview • History of CMS involvement in Clinical Trials • Initial implementation of modifiers at MD Anderson • Required retraining • Identified Concerns • Future Directions • New Findings • Questions for Discussion

3. CMS Historical Involvement in Clinical Trials • June 7, 2000 executive memorandum issued by the President of US • Clinical Trial Policy (CTP) National Coverage Determination (NCD) issued by CMS • Authorized coverage and payment of the routine costs associated with participation in a clinical trial.

4. Modifications of CMS Rules • July 9, 2007 issued a memo that preserves the 2000 NCD with a couple of changes: • Items that would be covered off protocol should also be covered on protocol • Evidence that the trial may work is required.

5. Changes to the 2000 CTP • Renaming of the policy to Clinical Research Policy • Process must be established that study meets scientific and technical standards: • Subject of the study must fall within Medicare benefit service. • Must have a therapeutic intent. • Must enroll patients with a diagnosed disease.

6. Additional New Requirements • Tx potentially improves health outcomes • Well-supported by scientific & medical information • Does not unjustifiably duplicate existing studies • Is appropriate to answer the research question • Sponsored by a credible organization • In compliance with Federal regulations • Conducted with scientific integrity

7. The Introduction of Modifiers • Effective 1/1/08 CMS mandated that modifiers be placed on all qualifying trials. • This was not transmitted until 1/18/08. • Trailblazers, our fiscal intermediary for CMS, required immediate compliance. • Resulted in our institution holding $38M+ of Medicare charges until a system was in place.

8. Modifiers to be Used • Instituted Q0, Q1, and R0 modifiers: • Q0-investigational clinical service • Items or services that are being investigated as an objective of a study. This is regardless of if the item is approved, unapproved, or covered/not covered by Medicare. • Q1- routine clinical service • Standard of care procedures that are being done to care for the patient. The services would be done regardless of of the patient being on a study.

9. Modifiers to be used, Cont. • R0-investigational clinical services • Services paid for by the sponsor. • Considered a pivotal step by CMS to better understand what investigational and routine services are being billed while a patient is on a clinical trial.

10. MD Anderson’s Initial Response • New CSR (Clinical Service Requisition) was developed that included columns for modifiers. • Fields were identified in the scheduling system to accommodate the modifiers.

11. MD Anderson’s Initial Training • Mandatory training classes began on 6/1/2008 for all involved in clinical research. • At these trainings the new mandate was discussed as well as consequences for noncompliance. • Introduction to the new CSR and scheduling system • Explanation of how to identify which modifier to utilize • New CSR was rolled out on 7/1/08 • After this initial training compliance was not at expected levels.

12. MD Anderson’s Additional Training • The GI Medical Oncology Department (GIMO) was identified to have the best practice in place and had excellent compliance. • They were asked to join in retraining other departments and share their processes. • Training classes were held in each department including research nurses, data coordinators, and schedulers • GIMO shared their internal auditing process as well as “good” and “bad” orders to explain what needs to occur to make an order clear to auditors, etc. • Further concerns about the process were identified and discussed.

13. Results of Retraining • After the retraining the compliance rate increased. • Since this time we have worked toward further compliance training thus ensuring compliance • At this time we still have a double-check system in place. This will remain in place until we have an effective electronic system.

14. Identified Concerns • The need to have the research CSR combined with the routine CSR for ease of ordering and less paperwork to complete • Manual entry of the modifiers and multiple hand offs prior to increases the likelihood of errors occurring. • Rescheduling of appointments created a lot of errors because the modifiers are not “taken with” the appointment. • Special lab tests that must be scheduled with diagnostic center have been scheduled without modifiers.

15. Future Directions • Moving toward automating modifiers into the protocol. • Bringing Velos online within the institution will help with automation • Modifiers will be built into the procedure completion screen in Velos which enables automatic transmission to the billing systems. • Electronic order entry with mandatory modifiers or NA included

16. New Findings • In the month of April 2010, we had our first request from a commercial insurance company for modifier information. • Since then we have had multiple major insurance companies asking for this data. • We see this as a trend for the future among all insurance companies.

17. Questions for Discussion • What if any impact will state laws for coverage of clinical trials have on modifier reporting? • How will the modifiers being provided to insurers affect preauthorization for participation in clinical trials?

19. The Perfect Rose

20. References • CMS Manual System PUB 100-03 Transmittal 74 Dated 9/17/07 • http://www.cancer.gov/clinicaltrials/ctlaws-home • Meade&Roach LLP Compliance Advisory: New CMS Research Modifier Rules • MD Anderson Cancer Center Clinical Research Finance

21. Thank you • Donna Griffith, RN- Clinical Research Finance • Mary Veazie, MBA- Clinical Research Finance • Yvonne Lassere, RN- GI Medical Oncology